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GHB, Conspiracy, and Suicide

GHB, Conspiracy, and Suicide - Page 2

How one man's fight to elevate a sleep and fibromyalgia aid cost him his life as the FDA turned a societal dilemma over "crossover" drugs into a nightmare crime.

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GHB addiction is poorly understood but there are enough accounts of its withdrawal syndrome that we know it can be a very dangerous drug. In August of 2003, Mike Scarcella, a 39-year-old former Mr. America and father of a five year old son, died of GHB withdrawal while in a psych ward he had been sent to because of his withdrawal symptoms. Like many bodybuilders, Scarcella first turned to GHB in the eighties. He used it to help him fall asleep, to help him get through the day, and to stay motivated throughout his workouts. Its dangers, at the time, were underreported, and Scarcella trusted the drug because it was marketed as a natural supplement. It wasn't long before he was taking it every few hours and his dependence quickly turned into a full scale addiction.

After becoming a father, Scarcella tried to detox several times, but the lure of the drug was always too strong and he always went back. After losing his bodybuilding and training career to the drug’s effects, he started selling GHB. While homemade “kitchen GHB” was everywhere, Scarcella always had the pure stuff and he became a popular dealer. Eventually he met up with the wrong guys and got beaten up outside of a bar. When he was taken to the emergency room, he made sure to tell the hospital staff that he was addicted to GHB. He knew he would soon be in the throes of withdrawal.

Trinka Porrata, a retired LAPD supervisor and expert on “trendy drugs of abuse”—including GHB, ecstasy, Rohypnol, and Ketamine—and president of Project GHB, a clearinghouse and non-profit organization started by a couple who lost their son to a GHB overdose, claims that the GHB withdrawal is worse than kicking heroin. “It's the worst withdrawal there is…Most detox takes four to five days. GHB can mean 10 to 14 days of really bizarre and psychotic behavior. The withdrawal itself can be lethal." People coming off a GHB habit will experience anxiety, depression, hypertension, nausea, hallucinations, psychosis, and agitation. Unfortunately, since GHB remains largely under the radar when it comes to treatment, most facilities are not equipped to deal with the detox.

In Mike Scarcella’s case, the hospital he was taken to after his fight did not know how to deal with someone coming off GHB. Scarcella stayed in intensive care for 10 days, fighting a staph infection and pneumonia in addition to going through a hellish withdrawal. By the tenth day his hallucinations and agitation were so bad that he had to be strapped to the bed. As a result of his extreme behavior, the hospital transferred him to a psych ward and detox, claiming he was “outside their scope of treatment.” That same night, his first in the psych ward, Mike Scarcella died. Preliminary findings claimed that Scarcella died from a subdural hematoma that occurred as a result of him banging his head on the floor in the psych ward. The medical examiner's final report says that Scarcella suffered "sudden cardiac death" as a result of an enlargement of the heart and GHB withdrawal.

Although Dr. Peter Gleason was allowed to return home after refusing to cooperate in a case against Jazz Pharmaceuticals, his troubles were far from over. Shortly after the incident with the police, Gleason was indicted on federal charges. The press release from the Department of Justice has a glaring headline: “Psychiatrist Charged with Conspiracy to Illegally Market the Prescription Medication Xyrem, Also Known as "Ghb," for Unapproved Medical Uses on Behalf of its Manufacturer.” The release goes on to state that Gleason is being charged “with federal crimes arising from his participation in a nationwide scheme to unlawfully promote the medication Xyrem, also known as sodium oxybate and gamma-hydroxybutyrate (“GHB”), to prescribing physicians for non-approved medical purposes… Specifically, GLEASON was charged with introducing a misbranded drug into interstate commerce, health care fraud, and conspiracy to commit those offenses.”

According to the indictment, Gleason was deceptive and misleading in his presentations about the drug, claiming that GHB was not actually a date rape drug and that it was safe and effective even when given to children (Xyrem labeling specifically mentions that its safety has not been established in pediatric populations). Additionally, the government charged Gleason with conspiring with the pharmaceutical company to use dishonest means to get the drug paid for by advising physicians to hide the fact that the prescription was being filled for an “off-label” use that might not qualify for reimbursement. Gleason acknowledged that although he had, on occasion, advised doctors to leave the diagnosis out of the prescription request, he never told anyone to lie. The press release quotes FBI Assistant Director-in-Charge Mark J. Mershon: “Apparently motivated solely by greed, someone whose moral and professional obligation was patient well-being engaged in a pattern of promoting unproven and even unsafe uses of a potentially dangerous drug. That a psychiatrist would engage in conduct indistinguishable from a carnival snake-oil salesman is appalling.”

By all accounts, Peter Gleason was acting in good faith when he recommended Xyrem to other physicians. He denied that he was ever irresponsible in his presentations and maintained his innocence, citing First Amendment rights and the FDA’s own rules that allow for physicians to receive compensation from drug companies for talking about their products. Gleason believed, and this seems to be supported by a paper trail, that the government only decided to go after him because he refused to participate in the case against Jazz Pharmaceuticals. A letter from an assistant United States attorney to the federal magistrate overseeing Gleason’s case asks that the case remain quiet because Gleason might “be willing to cooperate with this office in its broader investigation.” When Gleason went to Jazz for help, the company said he would have to fight the indictment on his own because they were now cooperating with the federal investigation. “They’re just cutting me loose,” Gleason said at the time.

Fighting the charges ruined Gleason financially and professionally. The government included something called a “criminal forfeiture allegation” in the indictment which required Gleason to give the government “any property, real and personal, that constitutes or is derived, directly or indirectly, from gross proceeds traceable to the commission of offenses.” Nearly all of Gleason’s income came from his medical practice and his presentations for Jazz. Consequently he was unable to afford a lawyer and was assigned free legal representation. He was also unable to find work anywhere. He filled in at various hospitals, but most places were unwilling to hire a physician who was fighting a federal indictment.

Eventually Gleason accepted a bargain—plead guilty to a misdemeanor conspiracy with the pharmaceutical company, receive one year of probation and pay a $25 fine. By this point Gleason was worn out and depressed, his pride was at an all-time low, his medical license was in question, and he could not find work. Harvey Silverglate, who used Gleason’s case in a book he wrote about how the feds target innocent people, says that Gleason was despondent the last time he spoke to him. On February 11, 2011, Peter Gleason committed suicide by hanging himself.

Fibromyalgia is a poorly understood and controversial condition that affects approximately five million adults in the United States. It is a central nervous system disorder that is characterized by persistent pain and fatigue. It is often associated with chronic fatigue syndrome, a condition which causes flu-like exhaustion and low energy. The drugs that have been used to treat these syndromes have not been successful at eliminating all of the associated symptoms that render these disorders so incapacitating. In several large clinical trials, however, Xyrem has been successful in treating these conditions. The theory is that Xyrem helps restore the “slow wave” sleep that is disturbed in people with Fibromyalgia and CFS.

Peter Gleason’s “snake oil” began to rise in popularity as an off-label treatment for exactly what he prescribed it for, and the empirical evidence backed it up. Anecdotally, Xyrem is viewed as a miracle cure by some sufferers. “It's too bad that Xyrem isn't more available for those with FM. After taking my first dose, I felt like I'd gotten my mind back, thinking clearly all day and not feeling the need for a nap. It's changed my life tremendously for the better,” writes one person on a message board.

Jazz Pharmaceuticals did eventually request approval for Xyrem to be labeled to treat fibromyalgia, but their application was rejected by the FDA who claimed that the drug could be abused too easily. Consequently patients who are prescribed Xyrem to treat fibromyalgia have to pay upwards of $1,000/month for their prescription, making it prohibitive for most people. “I used Xyrem for 6 years and my fibro pain went away. They were 6 wonderful years of great sleep as well,” writes “H.” However, since the drug is still not FDA approved to treat fibromyalgia, she can no longer afford it: “But then my insurance company said I could no longer get it as I did not have narcolepsy. It now costs near to $3,000 a month.”

Two years after Peter Gleason committed suicide, his case was overturned on appeal. Alfred Caronia, a salesman for Xyrem who was named as Gleason’s co-defendant on the indictment, finally got the court to listen to the point that Gleason had been making throughout his whole ordeal: “The First Amendment protects the right of physicians, drug manufacturers, sales representatives and anyone else who wishes to convey truthful, factual information about the beneficial uses of drugs in the relief of illness and pain.”

Dr. Gleason’s support of Xyrem never wavered, even in the midst of his legal troubles. His off-label prescribing is now vindicated by clinical and anecdotal evidence, and he finally (posthumously and by proxy) got the federal government to grant him his First Amendment rights. Unfortunately, he’s not here to celebrate these victories.

Allison McCabe is Senior Editor of The Fix. She last wrote about ambien.

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